Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Respironics California LLC V60/V60 Plus Ventilator [PCBA Part Number: 453561544461; V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)] [HKMD No.: 190021].
According to the FDA, Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93015
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Oct 2023